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SENATE FLOOR VERSION
February 22, 2021
COMMITTEE SUBSTITUTE
FOR
SENATE BILL NO. 638 By: McCortney
An Act relating to pharmacy; amending 59 O.S. 2011,
Section 367.2, which relates to definitions us ed in
the Utilization of Unused Prescriptio n Medications
Act; adding definition; amending 59 O.S. 2011,
Section 367.3, as amended by Secti on 45, Chapter 475,
O.S.L. 2019 (59 O.S. Supp. 2020 , Section 367.3),
which relates to program for utilization of unuse d
prescription drugs; deleting procedure for transfer
of certain prescription drugs; providing for donation
or return of unused prescription medications for
credit or reimbursement; excluding certain drugs;
amending 59 O.S. 2011, Section 367.4, which relates
to criteria for accepting unused prescription drugs;
broadening criteria to apply to returned drugs;
amending 59 O.S. 2011, Section 367.5, which relates
to participation in program ; clarifying inclusion of
certain facilities; specifying ability to refuse
individual returns; authorizing pharmacy to restock
and redistribute returned prescription drugs after
credit or reimbursement; amending 59 O.S. 2011,
Section 367.6, which relates to l iability of
participating organizations and manufacturers;
broadening criteria to apply to returned drugs;
removing certain pharmacies from program; clarifying
inclusion of certain facilities; amending 59 O.S.
2011, Section 367.7, which relates to promulgation of
rules; directing promulgation of certain rules; and
providing an effective date.
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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SECTION 1. AMENDATORY 59 O.S. 2011, Section 367.2, is
amended to read as follows:
Section 367.2. As used in the Utilization of Unused
Prescription Medications Act:
1. “Assisted living center” has the same meaning as such term
is defined in Section 1 -890.2 of Title 63 of the Oklahoma Statutes;
2. “Cancer drugs” means any of several drugs that control or
kill neoplastic cells, commonly referred to as “cancer-fighting
drugs”; and includes, but is not limited to, drugs used in
chemotherapy to destroy cancer cells;
3. “Charitable clinic” means a charitable nonpro fit corporation
or a facility organized as a not-for-profit organization pursuant to
the provisions of the Oklahoma General Corporat ion Act that:
a. holds a valid exemption from federal income taxation
issued pursuant to Section 501(a) of the Internal
Revenue Code (26 U.S.C., Section 501(a)) ,
b. is listed as an exempt organization under 501(c) of
the Internal Revenue Code (26 U.S.C., S ection 501(c)),
c. provides on an outpatient basis for a period of less
than twenty-four (24) consecutive hours to persons not
residing or confined at such faci lity advice,
counseling, diagnosis, treatment, surger y, care or
services relating to the preserv ation or maintenance
of health, and
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d. has a licensed outpatient pharmacy;
4. “Health care professional ” means any of the following
persons licensed and authorized to prescribe and dispense drugs or
to provide medical, dental, or other health -related diagnoses, care
or treatment within the scope of their professional license:
a. a physician holding a current license to practice
medicine pursuant to Chapter 11 or Chapter 14 of Title
59 of the Oklahoma Statutes this title,
b. an advanced practice nurse licen sed pursuant to
Chapter 12 of Title 59 of the Oklahoma Statutes this
title,
c. a physician assistant licensed pursuant to Chapter 11
of Title 59 of the Oklahoma Statutes this title,
d. a dentist licensed pursuant to Chapter 7 of Title 59
of the Oklahoma Statutes this title,
e. an optometrist licensed pursuant to Chapter 13 of
Title 59 of the Oklahoma Statutes this title, and
f. a pharmacist licensed pursuant to Chapter 8 of Title
59 of the Oklahoma Statutes this title;
4. 5. “Medically indigent” means a person eligible to receive
Medicaid or Medicare or a person who has no health insurance and who
otherwise lacks reasonable means to purchase prescribed medications;
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5. “Charitable clinic” means a charitable nonpro fit corporation
or a facility organized as a not-for-profit pursuant to the
provisions of the Oklahoma General Corporation Act that:
a. holds a valid exemption from federal income taxation
issued pursuant to Secti on 501(a) of the Internal
Revenue Code (26 U.S.C., Section 501(a)),
b. is listed as an exempt organization under 501(c) of
the Internal Revenue Code (26 U.S.C., Section 501(c)),
c. provides on an outpatient basis for a period of less
than twenty-four (24) consecutive hours to persons not
residing or confined at such facility advice,
counseling, diagnosis, treatment, surgery, care or
services relating to the preservation or maintenance
of health, and
d. has a licensed outpatient pharmacy; and
6. “Nursing facility” has the same meaning as such term is
defined in Section 1-1902 of Title 63 of the Oklahoma Statutes; and
7. “Prescription drug” means a drug which may be dispense d only
upon prescription by a health care professional authorized by his or
her licensing authority and which is approved for saf ety and
effectiveness as a prescription drug under Section 505 or 507 of the
Federal Food, Drug and Cosmetic Act (52 Stat. 1040 (1938), 21
U.S.C.A., Section 301).
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SECTION 2. AMENDATORY 59 O.S. 2011, Section 367.3, as
amended by Section 45, Chapter 475, O.S.L. 2019 (59 O.S. Supp. 2020,
Section 367.3), is amended to re ad as follows:
Section 367.3. A. The State Board of Pharmacy shall implement
statewide a program consistent with public heal th and safety through
which unused prescription drugs, other than prescription dr ugs
defined as controlled dangerous substances in Section 2-101 of Title
63 of the Oklahoma Statutes , may be transferred from residential
care homes, nursing facilities, assis ted living centers, public
intermediate care facilities for individuals with inte llectual
disabilities (ICFs/IID) or pharmaceutica l manufacturers to
pharmacies operated by a county. If no county pharmacy exists, or
if a county pharmacy chooses not to part icipate, such unused
prescription medications may be transferred to a pharmacy op erated
by a city-county health department or a ph armacy under contract with
a city-county health department, a pharmacy operated by the
Department of Mental Health and Substan ce Abuse Services or:
1. Donated by a residential care home, a nursing facility, an
assisted living center, an intermediate care facility for
individuals with intellectual disabilities (ICF/IID) or a
pharmaceutical manufacturer to a charitable clinic for the purpose
of distributing the unused pre scription medications to Oklahoma
residents who are medically indigent; or
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2. Returned by a residential care home, a nursing facility, an
assisted living center or an intermediate care facility for
individuals with intellectual disabilities (ICF/IID) to the pharmacy
where the unused prescription medications were purchased in exchange
for credit or reimbursement. Returns under this paragraph shall not
be available for drugs purchased by the state Medicaid program.
B. The Board of Pharmacy shall promulgate rules and establish
procedures necessary to implement the program established by the
Utilization of Unused Prescription Medications Act.
C. The Board of Pharmacy shall provide technical as sistance to
entities who may wish to participate in the program.
SECTION 3. AMENDATORY 59 O.S. 2011, Section 367.4, is
amended to read as follows:
Section 367.4. The following criteria shall be used in
accepting unused prescription drugs for use under t he Utilization of
Unused Prescription Medi cations Act:
1. Only prescription drug s in their original sealed unit dose
packaging or unused injectables shall be accepted and dispensed
pursuant to the Utilization of Unused Prescription Medications Act;
2. The packaging must be unopened, except that cancer drugs
packaged in single-unit doses may be accepted and dispensed when the
outside packaging is opened if the single -unit-dose packaging has
not been opened;
3. Expired prescription drugs shall not be accep ted;
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4. A prescription drug shall not be accepted or dispensed if
the person accepting or dispensing the drug has reason to believe
that the drug is adulterated;
5. No controlled dangerous substances shall be accepted; and
6. Subject to the limitation s pecified in this section, unused
prescription drugs dispensed for purposes of a m edical assistance
program or drug product donation progra m, or unused prescription
drugs returned by a facility listed in Section 367.3 of this title
in exchange for credit or reimbursement, may be accepted and
dispensed under the Utilization of Unused Pre scription Medications
Act.
SECTION 4. AMENDATORY 59 O.S. 2011, Section 367 .5, is
amended to read as follows:
Section 367.5. A. Participation in the Utilization of Unused
Prescription Medications Act by pharmacies, nursing homes
facilities, assisted living centers, intermediate care facilities
for individuals with intellectual disabilities (ICF/IID), charitable
clinics or prescription dru g manufacturers shall be voluntary.
Nothing in the Utilization of Unused Prescription Medicat ions Act
shall require any pharmacy, nursing home facility, assisted living
center, intermediate care facility for individuals with intellectual
disabilities (ICF/IID), charitable clinic or prescription drug
manufacturer to participate in the program . Furthermore, a pharmacy
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that participates in the program shall have the right to refuse
individual returns of unused prescr iption medications.
B. A pharmacy or charitable clinic which meets the eligibility
requirements established in the Utilization of Unuse d Prescription
Medications Act may:
1. Dispense dispense prescription drugs d onated under the
Utilization of Unused Prescription Medications Act to persons who
are medically indigent residents of Oklahoma as establis hed in rules
by the State Board of Pharmacy; and
2. Charge. Such drugs shall not be resold . However, the
charitable clinic may charge persons receiving donated prescription
drugs a handling fee established by rule by the Board of Pharmacy.
C. A pharmacy which meets the eligibility requireme nts
established in the Utilization of Unused Prescription Medications
Act may restock and redistribute prescription drugs returned to the
pharmacy after the pharmacy has issue d the credit or reimbursement
to the facility or entity who purchased the prescription drugs.
D. A pharmacy or charitable clinic which meets the eligibility
requirements established and authorized by the Utilization of Unused
Prescription Medications Act which accepts donated prescription
drugs shall:
1. Comply with all applicable federal and state laws related to
the storage and distribution of dangerous drugs;
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2. Inspect all prescription drugs prio r to dispensing the
prescription drugs to determine that such drugs are not adulterated;
and
3. Dispense prescription drugs only pursuant to a prescription
issued by a health care professional .
D. Prescription drugs donated under the Utilization of Unuse d
Prescription Medications Act shall not be resold.
E. For purposes of the Utilization of Unused Prescription
Medications Act, reimbursement from governmental agencies to
charitable clinics shall not be considered resale of prescription
drugs.
SECTION 5. AMENDATORY 59 O.S. 2011, Section 367.6, is
amended to read as follows:
Section 367.6. A. For matters related only to the lawful
donation, return, acceptance, or dispensing of prescription drugs
under the Utilization of Unused Pr escription Medications Act, the
following persons and e ntities, in compliance with the Utilizatio n
of Unused Prescription Medications Act, in the absence of bad faith
or gross negligence, shall not be subject to criminal or civil
liability for injury other than death, or loss to person or
property, or professi onal disciplinary action:
1. The State Board of Pharmacy;
2. The Department of Mental Health and Substance Abuse
Services;
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3. Any prescription drug manufacturer, governmental entity,
nursing home facility, or assisted living cent er, intermediate care
facility for individuals with intellectual disabilities (ICF/IID)
donating or returning prescription drugs under the Utilization of
Unused Prescription Medications Act;
4. Any prescription drug manufact urer or its representative
that directly donates prescr iption drugs in professional samples to
a charitable clinic or a pharmacy under the Utilization of Unused
Prescription Medications Act;
5. Any pharmacy, charitable clinic or health care professional
that accepts or dispenses prescription drugs under the Utilization
of Unused Prescription Medicati ons Act; and
6. Any pharmacy, or charitable clinic, city-county pharmacy or
other state-contracted pharmacy that employs a health care
professional who accept s or can legally dispense prescription drugs
under the Utilization of Unused Prescription Medicat ions Act and the
Oklahoma Pharmacy Act.
B. For matters related to the donation, return, acceptance, or
dispensing of a prescription drug manufactured by the p rescription
drug manufacturer that is donated by any en tity under the
Utilization of Unused Presc ription Medications Act, a prescription
drug manufacturer shall not, in the absence of bad faith or gross
negligence, be subject to criminal or civil liability for injury
other than for death, or loss to person or property including, but
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not limited to, liability for failure to transfer or communicate
product or consumer information or the expiration date of the
donated prescription drug.
SECTION 6. AMENDATORY 59 O.S. 2011, Secti on 367.7, is
amended to read as follows:
Section 367.7. A. The State Board of Pharmacy shall promulgate
emergency rules by December 1, 2004, to implement the Utilization of
Unused Prescription Medications Act. Permanent rules shall be
promulgated pursuant to the A dministrative Procedures Act. Such
rules shall include:
1. Eligibility criteria for pharmacies and charitable clinics
authorized to receive and dispense donated prescri ption drugs under
the Utilization of Unused Prescription Medic ations Act;
2. Establishment of a formulary which shall include a ll
prescription drugs app roved by the federal Food and Drug
Administration;
3. Standards and procedures for transfer, acceptanc e, safe
storage, security, and dispensing of donated prescript ion drugs;
4. A process for seeking input from the State Departme nt of
Health in establishing provisions which affect nursing homes
facilities and assisted living centers;
5. A process for seeking input from the Department of Mental
Health and Substance Abuse Servi ces in establishing provisions which
affect mental health and substance abuse clients;
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6. Standards and procedures for inspecting donated prescription
drugs to ensure that the drugs are in comp liance with the
Utilization of Unused Prescription Medications Act and to ensure
that, in the professi onal judgment of the pharmacist, the
medications meet all federal and state standards for product
integrity;
7. Procedures for destruction of medications that are donated
which are controlled substances;
8. Procedures for verifying whether the pharmacy a nd
responsible pharmacist participating in the prog ram are licensed and
in good standing with the Board of Pharmacy;
9. Establishment of standards for ac ceptance of unused
prescription medications from assisted livi ng centers; and
10. Procedures for credit and reimbursement for returns of
unused prescription medications; and
11. Any other standards and procedures the Board of Pharmacy
deems appropriate or necessary to imple ment the provisions of the
Utilization of Unused Prescr iption Medications Act.
B. In accordance with the rules and procedures of the program
established pursuant to this section, a resident of a nursing
facility or assisted living cent er, or the represent ative or
guardian of a resident may donate unused presc ription medications,
other than prescription drugs defined as controlled dange rous
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substances by Section 2-101 of Title 63 of the Oklahoma Statutes,
for dispensation to medically in digent persons.
SECTION 7. This act shall become effective November 1, 2021.
COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES
February 22, 2021 - DO PASS AS AMENDED